Chronic multisymptom illness (CMI) is a serious condition that imposes an enormous burden of suffering on our nation’s veterans. Veterans who have CMI often have physical symptoms (such as fatigue, joint and muscle pain, and gastrointestinal symptoms) and cognitive symptoms (such as memory difficulties) and may have comorbid syndromes with shared symptoms (such as chronic fatigue syndrome [CFS], fibromyalgia, and irritable bowel syndrome [IBS]) and other clinical entities (such as depression and anxiety). For the purposes of this report, the committee defined CMI as the presence of a spectrum of chronic symptoms experienced for 6 months or longer in at least two of six categories—fatigue, mood and cognition, musculoskeletal, gastrointestinal, respiratory, and neurologic—that may overlap with but are not fully captured by known syndromes (such as CFS, fibromyalgia, and IBS) or other diagnoses.
Despite considerable efforts by researchers in the United States and elsewhere, there is no consensus among physicians, researchers, and others as to the cause of CMI. There is a growing belief that no specific causal factor or agent will be identified.
Many thousands of Gulf War veterans1 who have CMI live with sometimes debilitating symptoms and seek an effective way to manage their symptoms.
1Veterans are considered to have served in the Gulf War if they were on active military duty in the Southwest Asia theater of military operations during the period from the 1991 Gulf War (Operation Desert Storm) through the Iraq War (Operation Iraqi Freedom and Operation New Dawn). Although Afghanistan is not in the Southwest Asia theater of operations, for the purpose of this report veterans of the Afghanistan War (Operation Enduring Freedom) are included in the Gulf War veteran population.
Estimates of the numbers of 1991 Gulf War veterans who have CMI range from 175,000 to 250,000 (about 25–35% of the 1991 Gulf War veteran population), and there is evidence that CMI in 1991 Gulf War veterans may not resolve over time. Preliminary data suggest that CMI is occurring in veterans of the Iraq and Afghanistan wars as well. In 2010, a previous committee of the Institute of Medicine (IOM) recommended “a renewed research effort with substantial commitment to well-organized efforts to better identify and treat multisymptom illness in Gulf War veterans” (IOM, 2010).
THE CHARGE TO THE COMMITTEE
The present study was mandated by Congress in the Veterans Benefits Act of 2010 (Public Law 111-275, October 13, 2010). That law directs the secretary of veterans affairs “to enter into an agreement with the Institute of Medicine of the National Academies to carry out a comprehensive review of the best treatments for CMI in Persian Gulf War veterans and an evaluation of how such treatment approaches could best be disseminated throughout the Department of Veterans Affairs [VA] to improve the care and benefits provided to veterans.” In August 2011, VA asked that IOM conduct a study to address that charge, and IOM appointed the Committee on Gulf War and Health: Treatment for Chronic Multisymptom Illness. The complete charge to the committee follows.
The IOM will convene a committee to comprehensively review, evaluate, and summarize the available scientific and medical literature regarding the best treatments for chronic multisymptom illness among Gulf War veterans.
In its evaluation, the committee will look broadly for relevant information. Information sources to pursue could include, but are not limited to:
• Published peer-reviewed literature concerning the treatment of multisymptom illness among the 1991 Gulf War veteran population;
• Published peer-reviewed literature concerning treatment of multisymptom illness among Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn active-duty service members and veterans;
• Published peer-reviewed literature concerning treatment of multisymptom illness among similar populations such as allied military personnel; and
• Published peer-reviewed literature concerning treatment of populations with a similar constellation of symptoms.
In addition to summarizing the available scientific and medical literature regarding the best treatments for chronic multisymptom illness among Gulf War veterans, the IOM will:
• Recommend how best to disseminate this information throughout the VA to improve the care and benefits provided to veterans.
• Recommend additional scientific studies and research initiatives to resolve areas of continuing scientific uncertainty.
• Recommend such legislative or administrative action as the IOM deems appropriate in light of the results of its review.
THE COMMITTEE’S APPROACH TO ITS CHARGE
A multipronged approach was used to respond to the charge. A Systematic review was conducted to evaluate the scientific literature on therapies to eliminate or alleviate the symptoms associated with, or that define, CMI. Because many people who have CMI also have other unexplained conditions with shared symptoms (such as CFS, fibromyalgia, and IBS) and may have comorbid conditions (such as depression and anxiety), treatments recommended in guidelines or supported by evidence as summarized in systematic reviews for these related and comorbid conditions also were reviewed to identify any treatments potentially beneficial in people who have CMI.
Managing patients who have CMI involves more than administering a therapy. It requires a broader view of treatment. To explore other aspects of care, the committee drew on multiple sources (such as the scientific literature, government reports, care programs used by organizations, an analysis of social media, and testimony from veterans and their families) so that it could make recommendations to VA about improving its model of care for veterans who have CMI, educating VA clinicians to improve their knowledge about how to care for these patients, and improving communication between clinicians and patients who have CMI.
FINDINGS, CONCLUSIONS, AND RECOMMENDATIONS
The committee’s findings, conclusions, and recommendations are in five major categories:
1. Treatments for CMI.
2. The VA health care system as it is related to improving systems of care and the management of care for veterans who have CMI.
3. Dissemination of information through the VA health care system about caring for veterans who have CMI.
4. Improving the collection and quality of data on outcomes and satisfaction of care for veterans who have CMI and are treated in VA health care facilities.
5. Research on diagnosing and treating CMI and on program evaluation.
Treatments for Chronic Multisymptom Illness
The committee conducted a de novo systematic assessment of the evidence on treatments for symptoms associated with CMI. The committee also identified evidence-based guidelines and systematic reviews on treatments for related and comorbid conditions (fibromyalgia, chronic pain, CFS, somatic symptom disorders, sleep disorders, IBS, functional dyspepsia, depression, anxiety, posttraumatic stress disorder, traumatic brain injury, substance-use and addictive disorders, and self-harm) to determine whether any treatments found to be effective for one of these conditions may be beneficial for CMI. Both pharmacologic and nonpharmacologic treatments were assessed. Holistic and integrative treatment approaches were considered in addition to individual interventions.
Studies of treatments for the symptoms associated with CMI conducted in the 1991 Gulf War veteran population were included in the assessment, as were studies conducted in different populations who had a similar constellation of symptoms. The generalizability of studies of nonveterans to veterans is not known.
The best available evidence from studies of treatment for symptoms of CMI and related and comorbid conditions demonstrates that many veterans who have CMI may benefit from such medications as selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors and cognitive behavioral therapy. On the basis of the evidence reviewed, the committee cannot recommend any specific therapy as a set treatment for veterans who have CMI. However, for the reasons outlined below, the committee believes that a “one-size-fits-all” approach is not effective for managing veterans who have CMI and that individualized health care management plans are necessary. The condition is complex and not well understood, and it will require more than simply treating veterans with a set protocol of interventions.
Recommendation 8-1. The Department of Veterans Affairs should implement a systemwide, integrated, multimodal, long-term management approach to manage veterans who have chronic multisymptom illness.
VA already has several programs—for example, postdeployment patient-aligned care teams (PD-PACTs), Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO) programs, and the War-Related Illness and Injury Study Center (WRIISC) program— that could be used to effectively manage veterans who have CMI. However, the programs have not been consistently implemented through the VA
health care system. Furthermore, the programs have not been adequately evaluated to learn about their strengths and weaknesses so that changes can be made to improve the quality of care.
Improving Care for Veterans Who Have Chronic Multisymptom Illness
The first step in providing care for veterans who have CMI is to identify them and to move them into VA’s health care system so that they can receive proper care for their CMI and any common comorbidities.
Recommendation 8-2. The Department of Veterans Affairs (VA) should commit the necessary resources to ensure that veterans complete a comprehensive health examination immediately upon separation from active duty. The results should become part of a veteran’s health record and should be made available to every clinician caring for the veteran, whether in or outside the VA health care system. Coordination of care, focused on transition in care, is essential for all veterans to ensure quality, patient safety, and the best health outcomes. Any veteran who has chronic multisymptom illness should be able to complete a comprehensive health examination.
Recommendation 8-3. The Department of Veterans Affairs should include in its electronic health record a “pop-up” screen to prompt clinicians to ask questions about whether a patient has symptoms consistent with the committee’s definition of chronic multisymptom illness.
Once a veteran has been identified as having CMI and has entered the VA health care system, the next step is to provide comprehensive care for the veteran, not only for CMI but also for any comorbid conditions. VA has developed multiple clinical practice guidelines (CPGs) for medically unexplained symptoms and common comorbidities and conditions with shared symptoms; however, there is anecdotal evidence that simply adhering to multiple CPGs often is not effective for managing chronic conditions with multiple morbidities such as CMI and can result in incomplete care and increase the likelihood of overtreatment and adverse side effects. Rather, a unique personal care plan for each veteran is required for effective management of the health of veterans who have CMI.
VA’s PD-PACTs, which use a team approach to providing coordinated, comprehensive, integrated care, should be able to provide care for veterans who have CMI if properly implemented. The move to the PACT model of care is relatively recent in VA’s health care system, and implementation efforts are ongoing.
Recommendation 8-4. The Department of Veterans Affairs (VA) should develop patient-aligned care teams (PACTs) specifically for veterans who have chronic multisymptom illness (CMI; that is, CMI-PACTs) or CMI clinic days in existing PACTs at larger facilities, such as VA medical centers. A needs assessment should be conducted to determine what expertise is necessary to include in a CMI-PACT.
Recommendation 8-5. The Department of Veterans Affairs should commit the resources needed to ensure that patient-aligned care teams have the time and skills required to meet the needs of veterans who have chronic multisymptom illness as specified in the veterans’ integrated personal care plans, that the adequacy of time for clinical encounters is measured routinely, and that clinical case loads are adjusted in response to the data generated by measurements. Data from patient experience-of-care surveys are essential to assist in determining needed adjustments.
Recommendation 8-6. The Department of Veterans Affairs should use patient-aligned care teams (PACTs) that have been demonstrated to be centers of excellence as examples so that other PACTs can build on their experiences.
To address the challenges of bringing care to veterans who lack easy access to VA medical centers, VA adopted SCAN-ECHO programs in 2010. SCAN-ECHO programs are being developed to bring specialty care to veterans who live in rural and other underserved areas. The SCAN-ECHO programs work by connecting clinicians who have expertise in particular specialties through video technology to provide case-based consultation and didactics to isolated primary care clinicians who would otherwise not have access to care for their patients.
Another VA program is the WRIISC program, which was established in 2001 to serve combat veterans who had unexplained illnesses. Veterans are generally referred to a WRIISC (there are three nationwide) by their clinicians when they are not improving and further local expertise is not available. Veterans in WRIISCs are evaluated by a multidisciplinary team that conducts a comprehensive health assessment and formulates a comprehensive personal care plan aimed at managing symptoms and improving functional health. Although WRIISCs have been in place for more than a decade, the committee does not have information on awareness of the program among the teams of professionals caring for veterans who have CMI or among the veterans themselves. Information also is lacking on the effectiveness of the program.
Recommendation 8-7. The Department of Veterans Affairs (VA) should develop a process for evaluating awareness among teams of professionals and veterans of its programs for managing veterans who have chronic multisymptom illness, including patient-aligned care teams (PACTs), specialty care access networks (SCANs), and war-related illness and injury study centers (WRIISCs); for providing education where necessary; and for measuring outcomes to determine whether the programs have been successfully implemented and are improving care. Furthermore, VA should take steps to improve coordination of care among PACTs, SCANs, and WRIISCs so that veterans can transition smoothly across these programs.
Dissemination of Information
Many opportunities exist for VA to disseminate information about CMI to clinicians. A major determinant of VA’s ability to manage veterans who have CMI is the training of clinicians and teams of professionals in providing care for these patients.
Recommendation 8-8. The Department of Veterans Affairs (VA) should provide resources for and designate “chronic multisymptom illness champions” at each VA medical center. The champions should be integrated into the care system (for example, the patient-aligned care teams) to ensure clear communication and coordination among clinicians.
The champions should be incentivized (for example, by professional advancement and recognition and value-based payment), be given adequate time for office visits with patients who have CMI, have knowledge about the array of therapeutic options that might be useful for treating CMI, have ready access to a team of other clinicians for consultation, and have training in communication skills. Smaller VA facilities, such as community-based outreach clinics, can benefit from CMI champions. For example, the SCAN-ECHO model can be used so that clinicians in community-based outreach clinics or even civilian community-based clinics can contact a CMI champion for expert consultation.
In addition to using CMI champions to train clinicians about CMI, learning networks have been found to be effective tools for disseminating information. Continuous exchange of information among learning networks can lead to improved quality of care. The networks offer a supportive environment for learning skills informally, role models, and a benchmark for an appropriate environment for adopting new practice guidelines.
Recommendation 8-9. The Department of Veterans Affairs (VA) should develop learning, or peer, networks to introduce new information, norms, and skills related to managing veterans who have chronic multisymptom illness. Because many veterans receive care outside the VA health care system, clinicians in private practice should be offered the opportunity to be included in the learning networks and VA should have a specific focus on community outreach.
Effective patient–clinician communication and coordination of care are crucial for managing veterans who have CMI and are the foundation of patient-centered care and decision making. They are essential for managing such patients successfully.
Recommendation 8-10. The Department of Veterans Affairs should provide required education and training for its clinicians in communicating effectively with and coordinating the care of veterans who have unexplained conditions, such as chronic multisymptom illness.
Improving Data Collection and Quality
As the committee conducted its assessment of treatments for CMI and of how this condition is managed in the VA health care system, it identified gaps in data on performance measurement. To assist VA in improving outcomes and ultimately to improve the quality of care that the VA health care system provides, the committee offers the following recommendation.
Recommendation 8-11. The Department of Veterans Affairs (VA) should provide the resources needed to expand its data collection efforts to include a national system for the robust capture, aggregation, and analysis of data on the structures, processes, and outcomes of care delivery and on the satisfaction with care among patients who have chronic multisymptom illness so that gaps in clinical care can be evaluated, strategies for improvement can be planned, long-term outcomes of treatment can be assessed, and this information can be disseminated to VA health care facilities.
The committee’s research recommendations are in two categories: treatments for CMI and research needs related to program evaluation.
Treatments for Chronic Multisymptom Illness. Many of the studies of treatments for CMI reviewed by the committee had methodologic flaws that limited their usefulness for the committee’s evaluation.
Recommendation 8-12. Future studies funded and conducted by the Department of Veterans Affairs to assess treatments for chronic multisymptom illness should adhere to the methodologic and reporting guidelines for clinical trials, including appropriate elements (problem– patient–population, intervention, comparison, and outcome of interest) to frame the research question, extended follow-up, active comparators (such as standard of care therapies), and consistent, standardized, validated instruments for measuring outcomes.
Examples of methodologic and reporting guidelines include those set forth by such organizations as the Agency for Healthcare Research and Quality and the Institute of Medicine and in such other efforts as the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Consolidated Standards of Reporting Trials statement.
On the basis of its assessment of the evidence on treatments for CMI, the committee found that several treatments and treatment approaches may be potentially useful for CMI. However, evidence sufficient to support a conclusion on their effectiveness is lacking.
Recommendation 8-13. The Department of Veterans Affairs should fund and conduct studies of interventions that evidence suggests may hold promise for treatment of chronic multisymptom illness. Specific interventions could include biofeedback, acupuncture, St. John’s wort, aerobic exercise, motivational interviewing, and multimodal therapies.
Program Evaluation. As noted above, the committee did not find comprehensive evaluations of VA programs, such as the PACTs, SCAN-ECHO programs, and WRIISCs. Program evaluation—including assessments of structures, processes, and outcomes—is essential if VA is to continually improve its services and research.
Recommendation 8-14. The Department of Veterans Affairs (VA) should apply principles of quality and performance improvement to internally evaluate VA programs and research related to treatments for chronic multisymptom illness (CMI) and overall management of veterans who have CMI. This task can be accomplished using such methods as comparative effectiveness research, translational research, implementation science methods, and health systems research.
IOM (Institute of Medicine). 2010. Gulf War and Health, Volume 8: Update of Health Effects of Serving in the Gulf War. Washington, DC: The National Academies Press. P. 261.